Transcranial Direct Current Stimulation for Peripheral Neuropathy

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Overseen ByZoe Sowers
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) to determine its effectiveness in reducing symptoms of chemotherapy-induced peripheral neuropathy (CIPN) in cancer survivors. CIPN can lead to numbness, tingling, pain, and movement issues following chemotherapy. The trial includes two groups: one receives active tDCS, and the other receives a placebo version before switching. Cancer survivors who experience numbness or pain after chemotherapy and can walk unaided might find this trial suitable. As an unphased trial, it offers a unique opportunity to explore innovative treatments that could enhance the quality of life for cancer survivors.

What prior data suggests that transcranial direct current stimulation is safe for treating chemotherapy induced peripheral neuropathy?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe for people. In past studies, tDCS did not cause any serious side effects. Participants most commonly reported minor side effects such as itching, tingling, headaches, and a burning sensation, all of which were temporary and not severe.

When used according to guidelines, studies have found tDCS to be well-tolerated. This non-invasive brain stimulation has been tested for various pain conditions and maintains a good safety record. Although the FDA has not specifically approved tDCS for treating peripheral neuropathy, it has been used safely for other types of nerve pain.

Overall, using tDCS to treat pain conditions appears safe, with only minor and temporary discomfort reported.12345

Why are researchers excited about this trial?

Unlike standard treatments for peripheral neuropathy, which often include medications like gabapentin or pregabalin that focus on symptom relief, transcranial direct current stimulation (tDCS) offers a non-invasive approach that targets the brain directly. tDCS uses a low electrical current applied to the scalp to stimulate the sensorimotor cortex, potentially altering pain perception and providing relief. Researchers are excited about tDCS because it has the potential to offer a drug-free alternative with fewer side effects, and it may provide quicker symptom relief compared to traditional medications.

What evidence suggests that transcranial direct current stimulation is effective for chemotherapy induced peripheral neuropathy?

This trial will compare the effects of active transcranial direct current stimulation (tDCS) with sham tDCS for peripheral neuropathy. Research has shown that tDCS can reduce pain in individuals with nerve-related pain conditions. In one study, participants experienced less pain after just three sessions of tDCS. Another study found that tDCS provided short-term relief for those with chronic nerve pain. This gentle brain stimulation method has also helped manage pain in conditions like fibromyalgia and migraines. Overall, tDCS appears promising in reducing pain and improving symptoms related to nerve issues.12346

Who Is on the Research Team?

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Brendan L McNeish

Principal Investigator

University of Michigan Rogel Cancer Center

Are You a Good Fit for This Trial?

This trial is for cancer survivors who developed nerve problems like numbness, tingling, or pain after chemotherapy. Participants should have ongoing symptoms of peripheral neuropathy caused by their treatment.

Inclusion Criteria

CIPN20 score ≥ 20
Proficient in English
I am between 18 and 85 years old.
See 4 more

Exclusion Criteria

Presence of metallic objects in the head
I have cancer that has spread to my brain.
Significant hearing or vision deficits
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo active or sham transcranial direct current stimulation (tDCS) to the sensorimotor cortex for 20 minutes, with a crossover after one week

3 weeks
Weekly visits for tDCS sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Transcranial Direct Current Stimulation

Trial Overview

The study compares real transcranial direct current stimulation (tDCS), a painless brain stimulation technique, to a sham (inactive) version to see if tDCS can reduce nerve-related symptoms in people with chemotherapy-induced neuropathy.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (active tDCS)Experimental Treatment2 Interventions
Group II: Arm II (sham tDCS)Placebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+

Citations

Transcranial Direct Current Stimulation in Neuropathic Pain

They found that pain intensity was significantly (p=0.015) reduced in only treatment group at the third session, relative to baseline.

Evaluating the efficacy of transcranial direct current ...

This review provides an overview of preclinical studies examining the effects of tDCS in rodent models of neuropathic pain.

Effects of Transcranial Direct Current Stimulation on pain ...

Conclusions: Our findings suggest that tDCS might be effective for fibromyalgia, migraine, and neuropathic pain associated with spinal cord ...

tDCS for Peripheral Neuropathy (NIBS4CIPN Trial)

Research has shown that transcranial direct current stimulation (tDCS) can help reduce pain and make it easier to manage. 4 weeks after treatment.

The Effects of Transcranial Direct Current Stimulation in ...

Conclusion: tDCS demonstrated significant short-term pain relief in patients with chronic intractable peripheral neuropathic pain. However, larger studies with ...

Randomized, Sham Controlled Trial of Transcranial Direct ...

A constant current with an intensity of 2 mA was used for a single 20-minute session. This protocol is safe and effective in patients with neuropathic pain [13] ...